AVID Medical, Inc. recalls Halyard PERC TRAY kit. Model Numbers: SLPC34-01
Reason for recall
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Lot / code information
- Model
- SLPC34-01
- UDI
- (Kit
- Lot #
- ): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641413, 1641414, 1641415, 1645684); 10809160459904 (1649576, 1660882, 1660883, 1660884, 1663896, 1665768). 2
- Model
- SLPC34-02
- UDI
- (Kit
- Lot #
- ): DHR 108916049515 NAV 10809160511213 (1668809, 1668810, 1668812, 1668813, 1668814, 1668815, 1668816)
What the firm is doing
Owens and Minor/Avid Medical notified consignees on about 03/13/2026 and then sent an updated letter on about 03/18/2026 with additional kits added to the affected product list. The notice explained the issue was initiated by Medline Industries, risk associated with syringe disconnection and loose connection, and instructed consignees to identify, segregate and quarantine all affected product, and to apply warning labels to affected AVID kits to ensure all users are aware of the actions requested by Medline. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure. All usage guidelines and the Instructions for Use are provided in Medline s recall letter. Consignees were also instructed to complete and return the Recall Response Form as well as to notify customers if affected kits were further distributed to ensure all end-users are appropriately notified and maintain records of effectiveness.
DistributionShow detailsHide
US distribution to FL, IL, MO, MS, NC, NE, TX.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1977-2026
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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